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| Technical Mgr, Ext Quality |
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| Job ID |
1000027954 |
| Requisition Number |
09-1000027954 |
| Location |
Hillsboro, OR |
| Job Category |
Quality |
| Shift |
N/A |
| Description |
Provide quality oversight to storage, movement, and distribution
of Clinical and Commercial materials including raw materials,
formulated bulk, final vial, and finished goods across Genentech
sites, as well as to and from partners, CMOs, and third party
contract distributors.
Provide quality guidance and support to Hillsboro Distribution Center (HDC) personnel. Serve as an expert and a single point of contact for multiple Genentech quality systems. Ensure site distribution operations and distribution contractors comply with cGMPs, Quality Agreements, and Genentech's distribution Quality Policies and procedures.
* Lead process improvement initiatives for Cold Chain and
distribution quality
* Troubleshoot and direct the resolution of complex Quality
issues by fostering effective interdepartmental and cross-functional partnerships
* Identify, design, and implement process and system
improvements.
* Manage department and cross-functional initiatives and
activities.
* Apply technical principles, expert judgment, and cross-
functional expertise to independently address a broad range of
complex problems related to distribution
* Serve as a trainer and train internal personnel (as needed)
on processes and systems related to Distribution Quality.
* Collaborate and author department policies and procedures.
* Be able to make decisions using a collaborative and cross
functional process
* Be able to apply good judgment and notify and escalate to
Management issues that may affect product quality or regulatory
compliance.
Requirements
* BA/BS in Life Science or equivalent experience.
* A minimum of 5 years of experience in the
pharmaceutical/biotechnology industry, distribution or distribution QA experience is preferred
* Demonstrated knowledge and proficiency in Quality processes
and systems
* Ability to interpret and apply Quality standards
* Strong communication skills, both verbal and written, ability
to communicate effectively across levels and organizational boundaries
* Maturity to work effectively while located at different site
from the manager
* Ability to build and maintain excellent relationships with
partner and customer groups
* Good judgment in decision making
* Business travel requirement is approximately 15% of work time
DIVISION: Quality GSC
REQUISITION NUMBER: 09-1000027954 |
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